Opportunity
[Japan] QA ITスペシャリスト
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About the role
Santen seeks a hybrid QA IT Specialist in Osaka to lead risk-based GxP computer system validation governance for ERP and other IT systems in Japan and globally. The role covers validation strategy and standardization, system implementation and UAT, quality review and approval support, access management, change control, training, issue resolution, and stakeholder consensus building. Required experience includes pharmaceutical or medical-device quality assurance and CSV experience.
Key requirements
- • At least 2 years of relevant experience
- • Required skills: Quality assurance experience in the pharmaceutical or medical device industry, GQP, GMP and GDP experience, Computer system validation (CSV) for implementation, change, operation and maintenance of ERP or major GxP systems, Risk-based validation lifecycle knowledge, Data integrity, Change control, Deviation and CAPA management, Audit response, Knowledge of major quality management system platforms, Understanding of GAMP 5 and validation lifecycle approaches, Japanese and English oral and written communication, Comprehensive validity, appropriateness and risk assessment, Ethical judgment and regulatory compliance, Computer system knowledge and evidence-based problem solving, Understanding of system architecture, data flows and business processes, Stakeholder engagement and consensus building across countries and departments
- • Required languages: Japanese, English
Opportunity details
- • Workplace: Hybrid
- • Posted: Oct 8, 2026
- • Original advert language: Japanese